Is there a Superior Anastomosis for Pediatric Crohn’s Disease? Morgan Richards, MD August 23,2012

Outline Case Presentation Background – Crohn’s Disease Indications for Operation Post-operative recurrence Hand-sewn vs.. stapled anastomoses Conclusions

WC 15 y/o boy PMH Crohn’s Disease dx 2009 Admitted for Crohn’s flare 7/25/2012 RLQ pain, decreased PO intake, RLQ mass Workup Colonoscopy MRE CT Ab/Pel Continued pain after medical management NPO, TPN, Zosyn

CT Abdomen and Pelvis

UGI with SBFT

WC 8/1/2012 Robot-assisted ileocecectomy with primary anastomosis for stricture Primary end to end anastomosis Interrupted Vicryl sutures, single layer closure

Background – Crohn’s Any portion of GI tract may be involved Segmental, discontinuous 60% involve TI 30% perianal disease

Background – Gross Pathology Gross Pathology Aphthous ulcers  stellate  coalesce Longitudinal ulcers surrounding edematous tissue  cobblestone Transmural Progressive inflammation leads to fibrotic scaring  stricture Fatty tissue from mesentery extends over serosa  creeping fat

Background - Micro Pathology Lymphoid aggregates thicken mucosa Non-caseating granulomas

Clinical Manifestations Three types of disease Stricturing Lumenal narrowing, fibrotic scar Obstructive symptoms Require operative intervention Perforating Sinus tracts Incite inflammation, adhesions, lead to fistulae Inflammatory Medical management for edema, inflammation

Operative Indications Not curative, palliative, preserve intestinal length Failure medical management Intestinal obstruction Enteric fistulae Abscess/inflammatory mass Hemorrhage Perforation Cancer Growth retardation

Types of Anastomoses

Risk Factors for Operation Neera et al 2006 Study design – Retrospective review 989 consecutive pts. with Crohn’s disease (age 1-17 at diagnosis) 6 centers Jan 2000-Nov 2003 IBD Consortium registry Median follow up 2.8 years (1day-16.7yrs) 128 pts. underwent surgery 17% by 5 yrs. from diagnosis 28% by 10 yrs. from diagnosis Risk for Surgery Female, initial dx UC, poor growth, abscess, fistula, stricture Protective factors Age 3-12 at diagnosis Fever at presentation Tx with infliximab or 5-aminosaliciylic acid

Disease Recurrence Definition Endoscopic, histologic, clinically symptomatic, radiographic, surgical Risk factors Smoking, penetrating disease, prior resection for CD, short duration of disease 1yr3yrs5yrs20yrs Endoscopic20-70%40-50% Second Operation 25-30%40-50% Clinical Criteria 10%30%50-60%

Rutgeerts Scoring System

Pediatric Recurrence Baldassano et al (CHOP) Retrospective review 79pts Inclusion Criteria Patients CD Dx, initial resective surgery Jan 1978 – Dec 1996 Exclusion Criteria >21 at first operation, perianal dz operations, abscess drainage, prior CD operation, strictureplasty Definition of disease recurrence Increase in PCDAI 30 over baseline + radiological, histological, endoscopic confirmation Response to escalation in medical therapy Study end points Recurrence of symptoms, death without recurrence, last available f/u Mean follow up 4.3yrs (range yrs.)

Pediatric Recurrence Baldassano et al Clinical recurrence rate 17% at 1 yr 38% at 3 yrs. 60% at 5 yrs. Risk factors for recurrence Preoperative use of 6-MP (1yr vs yrs., p < 0.005) Crohn’s disease limited to colon (p < 0.05) PCDAI (Increase > 30 points above baseline, p < 0.05) Limitations Retrospective, single institution Small patient population (type b error) Short follow up duration

Stapled vs. Hand sewn Anastomoses Cochran Review RCTs, 1125 pts. (441 stapled, 684 HS) 1980’s studies - cancer patients (825 pts.) 3 studies - non-cancer patients (264 pts.)  2 specifically CD Primary outcome Overall anastomotic leak (clinical or subclinical) Secondary outcomes Clinical anastomotic leak Radiological anastomotic leak Anastomotic stricture Anastomotic hemorrhage Time to perform anastomosis Reoperation 30-day mortality Intra-abdominal abscess Wound infection LOS

Stapled vs. HS in Crohn’s Disease Other outcomes – no difference in: Overall anastomotic leak Clinical anastomotic leak Re-operation Operative mortality Intra-abdominal abscess Wound Infection Stapled Leak Rate Hand sewn Leak Rate p - value All (1125 pts.)2.5%6%0.03* Cancer (825 pts.)1.3%6.7%< 0.05* Non-cancer (264 pts.) 5%4%> 0.05

Recurrence after Ileocolic Resection RCT, McLeod et al. 2009: Stapled vs. hand sewn anastomosis in ileocolic resection for crohn’s disease 170 pts. from 17 sites Intraoperative randomization, computer generated Two surgical techniques Hand sewn end to end with 2-0 PDS Stapled side to side functional end to end anastomosis Follow up 6wks, 3mo, 6mo, 9mo, 1yr (with colonoscopy)

Recurrence after Ileocolic Resection Inclusion Criteria Disease in distal ileum and right colon Scheduled, elective resection Exclusion Criteria Previous disease resection Required defunctioning ileostomy Unable to discontinue CD medications post-operatively

Recurrence after Ileocolic Resection Primary endpoint Endoscopic recurrence by Rutgeert’s score (i2, i3, i4) Secondary endpoint Symptomatic recurrence, endoscopic disease plus symptoms requiring medical or surgical treatment Time to construct anastomosis Duration of operation Post-operative complications Reoperative rate

Results Hand sewn 81pts (94%), hand sewn anastomosis with 2-0 PDS 60 (70%) in 1 layer, 26 (30%) in 2 layers Stapled 49 (58%) side to side 35 (42%) functional end to end Statistically significant outcomes Shorter time for anastomosis in stapled group (p = ) Shorter mean duration of surgery in stapled group (p = ) No difference in Median hospital stay Overall complication rate Leak rates Reoperative rates

Results Primary Endpoints: Hand sewn Anastomosis Stapled Anastomosis p - value Endoscopic Recurrence Rate 42.5% (31/73)37.9% (25/66)0.55 Symptomatic Recurrence Rate 21.9%22.7%0.92

Risk Factors for Recurrent Disease

Conclusions No definitive evidence for stapled or hand sewn anastomosis Stapled may be faster intraoperatively, but does not decrease overall length of stay or provide a mortality benefit Data remains inconclusive Low power Short duration of follow up Clinically poor primary endpoint

References Baldassano RN. Pediatric Crohn’s Disease: Risk factors for Postoperative Recurrence. Am. J Gastroenterology 2001; Gupta N. Risk Factors for Initial Surgery in Pediatric Patients with Crohn’s Disease. Gastroenterology 2006; 130: McLeod RS et al. Recurrence of Crohn’s Disease After Ileocolic Resection Is Not Affected by Anastomotic Type: Results of a Multicenter, Randomized, Controlled Trial. Dis Colon Rectum 2009; 52: Choy PYG, Bissett IP, Docherty JG, Parry BR, Merrie A, Fitzgerald A. Stapled versus hand sewn methods for ileocolic anastomoses. Cochrane Database of Systematic Reviews 2011, Issue 9. Swoger JM. Evaluation for Postoperative Recurrence of Crohn‘s Disease.Gastroenterology Clin N Am 2012;41: